Total enrolment is expected to be ∼1600 pts with mCRPC from 250 centres worldwide. Pts will receive CbzP (25 mg/m Q3W + 10 mg P oral QD) until progressive disease (PD), death, unacceptable toxicity, physician/pt decision or commercial availability of Cbz. Pts will be followed for 30 days after last administration for safety. Use of G-CSF is recommended as per ASCO guidance.

Results

Baseline and safety data from the first 919 pts enrolled in the 2 programmes in 30 countries are shown. Mean age was 68 yrs with 21.2% ≥ 75 yrs. All pts had ECOG ≤ 2; the most common sites of metastases were bone (91.7%), lymph nodes (regional 29.9% and distant 28.0%), lung (11.2%) and liver (9.9%). 16.8% had PD during their last D regimen. The median number of treatment cycles was 4 (range 1–16); median relative dose intensity (all cycles) was 99%. Among the 502 pts who stopped CbzP, the most common discontinuation reasons were PD (40.9%), adverse event (AE; 26.9%) and commercial availability of Cbz (15.8%). G-CSF was administered to 60.5% of pts (prophylactic and/or therapeutic use). Overall, 40.4% of pts had Grade 3–4 AEs possibly related to CbzP, the most common relevant being febrile neutropenia (FN; 6.1%), fatigue (3.6%), diarrhoea (3.0%) and nausea (1.0%). Of the 41 pts (4.5%) with AEs leading to death, 21 (2.3%) had at least 1 AE possibly related to CbzP.

Conclusion

These interim results provide additional safety data on CbzP use in the routine clinical practice setting across the globe. Treatment with CbzP was clinically manageable and FN rate was lower than in the TROPIC study, possibly due to the use of G-CSF as prophylaxis.

Disclosure

Z.I. Malik: Has participated in an advisory board for, and has received honoraria and funds to attend conferences from Sanofi,

G. Di Lorenzo: Has acted as a compensated consultant for Sotio and TEVA,

P. Parente: Has participated in an advisory board for, and has received research funding from, Sanofi,

W.R. Gerritsen: Has acted as a compensated consultant for Algaia Biomedical Ventures,

S. Hitier: Is a Sanofi employee (biostatistician) and owns shares in Sanofi,

A. Heidenreich: Has participated in advisory boards for Sanofi, Janssen Cilag and Astellas. Has received honoraria from,

Sanofi, Astellas, Amgen and Janssen Cilag,

A. Bahl: Has participated in an advisory board for, and received research funding from Sanofi.